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FDA 510(k)

InMode RF System

K-Number: K163190 · 2016-12-12

ApplicantInmode MD , Ltd.
Decision Date2016-12-12
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

InMode RF System is the device name listed in this FDA 510(k) record. The listed applicant is Inmode MD , Ltd.. It received FDA 510(k) clearance on 2016-12-12 under 510(k) number K163190. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the InMode RF System?

InMode RF System is a medical device that received FDA 510(k) clearance on 2016-12-12. The listed applicant is Inmode MD , Ltd.. The 510(k) number is K163190.

When did InMode RF System receive FDA 510(k) clearance?

InMode RF System received FDA 510(k) clearance on 2016-12-12, under 510(k) number K163190.

Who is the listed applicant for InMode RF System?

The FDA 510(k) record lists Inmode MD , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for InMode RF System?

The FDA product code for InMode RF System is GEI.

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Other records listing Inmode MD , Ltd. as applicant

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Related Devices (Code: GEI)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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